The laboratory must undergo an audit by the department, or
their primary accreditation authority (in cases of third party recognition), to
assess critical elements and areas of recommended practices. All directly
accredited laboratories will be audited on a triennial basis. The laboratory
must assist/accommodate department of ecology personnel during audits as
required. The department will determine if the audit will be on-site.
(1)
Critical elements for
accreditation. Elements of an environmental laboratory's operations
which are critical to the consistent generation of accurate and defensible data
are critical elements for accreditation. Critical elements are subject to
intense scrutiny throughout the accreditation process. The ecology accrediting
authority may deny, revoke, or suspend accreditation for deficiencies in
critical elements. Functional areas including critical elements are:
(a)
Analytical methods. By
conducting audits the department determines if SOPs and other documentation of
analytical methods:
(i) Are present at the
laboratory;
(ii) Are approved for
regulatory use, if applicable;
(iii) Readily available to analysts;
and
(iv) Being implemented. If the
laboratory is using a locally developed method, the audit may include an
evaluation of the adequacy of that method.
(b)
Equipment and supplies. The
audit seeks to determine if sufficient equipment and supplies as required by
analytical methods are:
(i)
Available;
(ii) Being adequately
maintained; and
(iii) In a
condition to allow successful performance of applicable analytical procedures.
To gain and maintain accreditation, laboratories must
demonstrate that equipment and supply requirements of applicable regulatory
programs are being met.
(c)
QA and QC records. The audit
includes a review of QA and QC records for programs/projects within which the
laboratory is generating analytical data for submission to the data
user.
(d)
Sample
management. The audit includes a review of applicable procedures for
receipt, preservation, transportation, and storage of samples. The laboratory
is responsible only for those elements of sample management over which it has
direct control. To gain and maintain accreditation, laboratories must
demonstrate that sample management requirements of applicable regulatory
programs are being met.
(e)
Data management. The audit includes a review of activities
necessary to assure accurate management of laboratory data including:
(i) Raw data;
(ii) Calculations; and
(iii) Transcription, computer data entry,
reports of analytical results.
To gain and maintain accreditation, laboratories must
demonstrate that data management requirements of applicable regulatory programs
are being met.
(2)
Recommended practices.
Recommended practices are those elements of laboratory operations which might
affect efficiency, safety, and other administrative functions, but do not
normally affect quality of analytical data. Normally these practices would not
be the basis for denial or revocation of accreditation status. Functional areas
within which recommended practices may be noted are:
(a)
Personnel. The department
seeks to determine if managerial, supervisory, and technical personnel have
adequate training and experience to allow satisfactory completion of analytical
procedures and compilation of reliable, accurate data. Minimum recommended
education and experience criteria for laboratory personnel are specified in the
procedural manual.
(b)
Facilities. The department seeks to determine if laboratory
facilities allow efficient generation of reliable, accurate data in a safe
environment.
(c)
Safety. The department may refer serious safety deficiencies to
appropriate state or federal agencies.
(3)
Drinking water laboratory
requirements. For laboratories applying for accreditation of drinking
water parameters, audit requirements are those designated in the drinking water
certification manual. If such a standard is more stringent than the
corresponding standard in this chapter, the drinking water certification manual
applies.
(4)
Documentation
requests. Laboratories must submit requested documentation to the
department at least two weeks prior to the scheduled start date of an audit. At
a minimum the documents submitted must include:
(a) Standard operating procedures for all
methods being audited;
(b)
Analytical data for each method being audited; and
(c) Additional documentation deemed necessary
by the department to conduct the audit.
